# K973417: Clinitex Stockinette

- Pathway: 510(k) (Traditional)
- Applicant: Clinitex Medical Corp.
- Decided: Dec 9, 1997 after 90 days
- Product code: LGF (Component, Cast)
- Device class: 1
- Regulation: 21 CFR 888.5940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.

Source page: https://510kreport.com/device/K973417
Methodology: https://510kreport.com/methodology